Wednesday, May 21, 2008

Brain Scams: The Marketing Of Functional Neuroimaging

The current issue of Wired Magazine carries an article I wrote about entrepreneurs who market different forms of functional neuroimaging for indications ranging from diagnosing psychiatric disorders to detecting lies. As part of my research for the article, I got SPECT scanned by Daniel Amen at the Amen Clinic in Newport Beach, and received a functional MRI by Cephos Corporation in Massachusetts. The bottom line is that functional neuroimaging is not ready for prime time in clinical settings, with very few exceptions, such as the use of PET scanning to differentiate frontotemporal dementia from Alzheimer's disease. In addition, Cephos and No Lie MRI's lie detection algorithms are intriguing, and may rival standard polygraphy if current research pans out.

I hope you'll read the article and let me know your thoughts. Thus far, most of the comments on the Wired website have been by either Dr. Amen or his supporters, who rely on patient anecdotes, rather than prospective clinical trials, to support the validity of SPECT in psychiatry. Clearly, there's a lot of money to be made in this business, and the allure of riches has clouded the judgments of otherwise well-meaning and intelligent clinicians.

Tellingly, one of the Amen Clinic's main competitors, Brain Matters, based in Denver, recently filed for Chapter 11 bankruptcy protection. This financial death spiral came shortly after the company was featured on the PBS Frontline show, The Medicated Child.

Functional neuroimaging has great promise for elucidating the neurocircuitry of psychiatric disorders, but most of the neuro-entrepreneurs are leapfrogging over the necessary studies to rush their products to market. It's time to slow down and do it right.

20 comments:

One of the pieces of information that Dr. Carlat left out of his article is that he came to our clinic and refused to fill out our intake questionnaires. He wanted me to act like a palm reader and tell him what the scans said without much clinical information. That is not how we practice. That is not how any reputable physician operates. We want all of the information, clinical information and scan information, before we make a diagnosis and prescribe a treatment plan. Yet having said that, I was right! He admits that his scan did in fact fit his clinical presentation. He says it was because I am a good doctor (thanks Danny). I would say it is because I am a good doctor with more information. Don’t you want your doctor to have as much information before he goes about changing your brain?

The following is a long comment that I posted on the Wired.com comments section, and which responds to several of the comments there, as well as to this comment by Dr. Amen:

I want to thank everybody for their spirited replies. To clarify a few points:

1. I do not denigrate functional neuroimaging in general. It has crucial applications in medicine, especially in neurology, cardiology, and oncology. In addition, in the article I state that it has at least one agreed upon application in psychiatry, and that it is a useful tool for researchers in the field. The clear consensus, however, is that it has no demonstrated utility in diagnosing the broad range of psychiatric disorders.

2. Regarding my visit with Dr. Amen, his claim that I “refused” to fill out a clinical questionnaire is false. In fact, I spent an hour answering all the questions on the questionnaire with one of his assistants before being scanned. In addition, Dr. Amen himself asked me these same questions during our final visit, and before he interpreted my scans. Nor did I in any way misrepresent the nature of my visit. Dr. Amen was fully aware that I was researching an article for Wired, and he was also aware that I was skeptical about the use of SPECT in psychiatry.

3. Although I was skeptical going in, I was prepared to be impressed by the technique. If I had felt that the images added information of value that was not obtained via the clinical interview, I would have been genuinely intrigued. However, this was not the case in my evaluation, nor have I been convinced that it has been the case for any other patient of Dr. Amen.

4. The fact that Dr. Amen has amassed 42,000 scans is not, in itself, evidence that the scans provide any value to patients. The required evidence was clearly outlined by Dr. Rubin: prospective studies in which patients with specific validated diagnoses are scanned, and in which the scans are then read blindly by experts. These are precisely the types of studies that persuaded Medicare to cover PET scans for differentiating fronto-temporal dementia from Alzheimer’s disease. I have not seen any similar studies for depression, ADHD, bipolar disorder, anxiety disorders, or any other psychiatric syndrome.

5. Finally, as I mentioned in the article, it is clear that Dr. Amen is an excellent clinician and has helped many people in his clinics. However, I believe that he helps people through a combination of careful listening, psychotherapy, and psychopharmacology. The results of SPECT scans are in most cases irrelevant to his patients’ improvement, other than adding to the placebo effect, which is always a large ingredient in psychiatric practice.

At the risk of being hypocritical as I have told Dr Carlat I was not commenting anymore here, after reading these 2 above comments by Dr Amen and Dr Carlat, I feel COMPELLED to say something through this commentary site.

"Don't you want your doctor to have as much information before he goes about changing your brain?"Is it truly just me, or is that one of the most outrageous comments to ever have heard a physician say about treatment interventions? I have met people who are noted by other colleagues to have been wonderful, caring physicians, but have come to be corrupted and jaded by these innovations or discoveries that sell this "panacea effect" that comes to be perhaps not a sham, but not an incredible advance over the standards we know in the field to be reliable and know the potential poisons.

I'm glad Dr C provided his follow up in this site. I think, for what little I know about Dr C, he is an invested and caring doc. I do worry about the optimism and idealism part though in this process of revealing inappropriate behaviors by others in our field. I don't care how jaded or cynical this comment will come across to others, but our colleagues are corruptable, as any one in any field can be. It is deeds, not words that define us. Don't just listen, but watch and observe the behaviors and attitudes, expecially out of the office.

read Trust Rules, it says it perfectly!!!

Sorry for not following through with what I said in the last email. I hope you'll print this.

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I have never seen Dr. Amen as a patient. I have no financial interest in his clinics or any facet of neuroimaging.

As a community mental-health volunteer, however, I have met many people who were helped by Dr. Amen after years (sometimes decades) of ineptitude by traditional clinicians. In my experience, 90% of psychiatrists are unimaginative, rigid thinkers who, as much as they like to say they aren't, are hidebound in a psychoanalytic mindset.

I believe without question what Dr. Amen says here about Carlat refusing to take the intake questionnaire,etc, because not only do I trust Dr. Amen implicitly, but I also know how arrogant too many psychiatrists can be.

They think they know it all. And in their closed office, with a vulnerable patient, there is nothing to interfere with that delusion. If a patient doesn't get better, they can blame it on "resistance" or not wanting to get better. How convenient. Palm reading, indeed.

But what about the patient who has brain damage from working in a factory with solvents for years? What about the patient who has childhood head trauma? The standard psychiatrist not only doesn't think to ask about these things but also considers them irrelevant. Even delusional.

For years, before it came "cool," Dr. Amen's approach has been holistic--from nutrition and retraining thought-patterns to factoring in chemical exposure and TBI--that anything about his approach would be foreign and therefore threatening to standard clinicians. And Amen has NEVER CLAIMED that the scans are diagnostic. That's been the naysayers' charge.

And sure there are some lazy clinicians who are "selling" these scans disreputably. But there are also psychiatrists who are still more focused on potty-training than neurotransmitters. Where's the outcry about them? They are surely bigger in number.

It's just mind-boggling to me that Carlat presents himself as a stickler for the studies, when he makes rash judgments born of nothing, seemingly, but his bias and emotions.

If only more psychiatrists would spend some time studying Amen's methods--instead of decrying them--we'd all be a lot better off. That, however, would probably take smaller egos and more compassion.

I think you've missed the point of my article. I'm not denying that Dr. Amen has helped many people; I'm convinced he has, and my own interaction with him was personally helpful, particularly a specific bit of cognitive therapy insight that he shared. My beef with him has to do with his promoting SPECT scanning as an aid to diagnosis. There simply is no convincing data that it adds anything of value in that regard. If you disagree, please cite the studies in support of your belief.

As far your opinion of psychiatrists, I'm just as willing to bash unimaginative, rigid thinkers as you are, but your critique here, as well, is misguided. The problem is not that psychiatrists are stuck in the psychoanalytic mind-set, but that they are stuck in the psychopharmacology mind-set. If you're going to bash, please bash accurately!

Finally, regarding this silly bit of he said/he said about the questionnaire, I'll just reiterate that I answered all the questions at length with Ronnette Leonard, the "historian" assigned to me. I then answered more of them with Dr. Amen himself. Hopefully Dr. Amen will chime in to at least verify these facts.

Did the Amen Clinic send an intake questionnaire to you prior to your visit? That, to my knowledge is their standard procedure.

I've been referring people to the website for years because it is one of the best intake forms I've seen. In fact, one litmus test I have for a competent clinician is their office sending out a good questionnaire to be completed before the first appointment. And when it comes to ADHD and other conditions where low insight is common, third-party input should be requested, too. (And to be sure, this is where the psychodynamic component still holds sway, because too many see this as a “boundary invasion” or assume that the loved one is probably part of the problem.)

If they did send it to you prior to your meeting, why didn't you fill it out? The meeting that you had with the clinician should have been based on your completed questionnaire. It was not a substitute for it.

Re: the rest

Here's the thing: I deal with real people, not abstractions. You might say psychiatrists do, too. But I deal with them as an equal and their educator, confidante and champion--not as their physician, in whose presence they are often intimidated.

So, maybe I have a little "front line" experience in these matters as concerns ADHD, anyway, and its comorbidities. Trust me, there is much that patients do not tell their psychiatrists. I know so many adults with ADHD who are even afraid to tell the doc that the treatment isn’t working, because either they don’t want to tell the doc he/she is failing or they don’t want to feel that they, the patients, are failing….at one more thing. Or that their case is truly hopeless. So, they will shine them on. “Yeah doc, going great.” But I hear otherwise.

Talk about working on the basis of flimsy research. Many docs conduct their own little “research” and conclude that the drug they’ve been pushing works because, well, their cognitive dissonace and selective perception precludes any other conclusion. But the facts, ah, they speak otherwise. Just don't ask to see any well thought-out database; it's all in their head! What? You question them? You must have an issue with authority.

For example, don’t even get me started on how many lives have been devastated due to docs’ rampant prescribing of a popular AMP medication—and most docs never had a clue. If they did, they wouldn't have kept tossing it out like Mardi Gras doubloons. Let’s just say, the reps for one particular company were extremely persuasive.

Every day, through my local advocacy work and through an international online support group, I am just flabbergasted at what too often passes for psychopharmacology. No protocols. No start-low-titrate-slow. Just pure winging it--with nary a thought that these patients will go out into the world and suffer possible side effects that could prove devastating. We call it “Meds Roulette.” And do they even bother to solicit feedback from a third-party, despite the fact that frontal-lobe conditions such as ADHD, bi-polar, and even anorexia typically confer low insight? No. It’s this treatment travesty that should be making headlines. Where’s the outrage here?

Dr. Amen certainly doesn’t need me to defend his work—and might well appreciate me butting out of the conversation because I am not professionally qualified to do so. But how can you be so sure you know which factors have contributed to his clinical skills, which you acknowledge as good?

From what I've seen, he is far more careful with his data--and has more solid evidence--than most "traditional" psychiatrists are with theirs.

Can you point to any specific instances where Dr. Amen has touted a scan's ability to diagnose standard psychiatric conditions? I haven't seen that, nor have I heard it from his patients. I've heard of it being used as one piece of the puzzle--and typically only after basic treatment has proved unsuccessful. And then it has been extremely helpful. Who before Amen was educating the public about the physical damage of the brain from substances (okay, the fried egg brain on drugs doesn’t count), chemicals, bumps on the head, etc.? His scans have helped him to do an amazing job of helping us to think of the brain as a physical structure. Where’s the double-blind study on that?

I've also seen many men, in particular, who are highly visual or concrete thinkers respond to a scan the way they would never respond to "some quack's" subjective opinions. How do you control for the value of that?

Where Amen’s SPECT research has been most useful to me--and to other readers of his books--is in the aggregate interpretations of brain patterns. They provide guideposts, not rigid slots.

Sorry to ramble on, but I’ve just finished a book for the partners of adults with ADHD and am a few neurons short of a neural pathway. It is an outgrowth of eight years of volunteer work, much of which has been educating about proper ADHD treatment protocols. And what has fueled me lo these many years is indignation at what passes for psychiatric care in this country.

You can read about it here:http://www.1201alarmpress.com/Reviews.html

Too many people have given up – for themselves or their children—due to lousy care and often horrible, unnecessary side effects. For that, we are now suffering an anti-medication backlash. Any psychiatrist or therapist would do well to spend more time learning from Dr. Amen’s books and less time debating abstractions.

3. Although I was skeptical going in, I was prepared to be impressed by the technique. If I had felt that the images added information of value that was not obtained via the clinical interview, I would have been genuinely intrigued. However, this was not the case in my evaluation, nor have I been convinced that it has been the case for any other patient of Dr. Amen.

--------P.S. Daniel, if you don't have a suspected brain disorder, brain trauma or injury, etc. why would you expect something significant to show up on the scan?

How can Rubin be so sure what constitutes the thing called "depression?" It sounds like he is expecting scan results to jibe with clinical pronouncements of depression.

Why is that problematic? Because many people are misdiagnosed with depression! And maybe scans will point to the differences among the conditions currently considered depression.

For example, for decades--and even now--people with ADHD have been diagnosed with depression. Yet, for many of them, their "depression" is the result of their undetected ADHD. Surely, that kind of "depression" would look different on a scan.

It is a shame your site attracts these zealots who think that saying "you are wrong" in 1000 words gives it validation. Some sayings are timeless:Full of sound and fury, signifying nothing.

Speaking of disclaimers, Ms Pera's dissertation needs one. I will be nothing less than surprised she has some involvement with this treatment. And, if I am truly wrong, then I stand corrected.

Life is about making a living, not a profit, especially when it comes to health care. How much money does this intervention cost and how much is profit? It is a fair question if the process is about helping people.

Therapy first (does this apply to a patient with schizophrenia, too?)--

Indeed, your attack on my motivation is dead wrong. I have been a volunteer for 8 years, giving up much paying work—and taking on a lot of grief--to do so. In fact, my husband is laughing hysterically at your unimaginative attack.

Gee, could your cheap shot say more about you and your own motives (and perhaps your brand of psychotherapy) than me and mine?

I do this work because I've seen too much of the damage wrought by dogmatic therapists and haphazard psychiatrists.

I set aside five years of my life to try to make a difference, and many people tell me I have. And a big part of that helping people to be smart mental health consumers and find an excellent professional.

It is my dream to have a Hall of Shame and Hall of Fame website, so that we can actually read about patients' experiences with mental healthcare providers. Too bad it's legally problematic.

I've stayed with the job longer than I expected because I didn't expect so many advanced-degreed professionals to be so selfish, science-phobic, and unempathic regarding their patients. It's been shocking, frankly.

You are right on one point, though. My response was way too long and rambling. As I mentioned, I'm tired, and Executive Function is slipping. It has been a long haul. I should not have posted at all, lest I muddied the waters.

But Carlat did that himself, by throwing together a hodgepodge of neuroimaging methods--and motives.

The facts are simple -- there is no demonstrated research studies that validate the use of any brain imaging technologies in mainstream clinical usage. None. Zero. You don't have to take my word for it, or Dr. Carlat's. Go look at the research yourself -- it's all right there in MEDLINE and PsycINFO.

Brain scans such as fMRI and SPECT are interesting research tools. But they are not accepted mainstream tools used for diagnosis or anything of the sort at this time. Mental disorders are diagnosed through simple symptom checklists.

I'm not a volunteer in this field; I have one thing to say, after interviewing over a dozen psychiatrists in Carlat's "league"; none of them warrented a SPECT. The cost alone (hello Newport Beach)is ridiculous, and the SPECT has no proof of working for what it says it should do. I have met patients who HAVE had a SPECT; they were told "their exact diagnoses and here are the medications to take for it". One person I met showed me his SPECT scan, and his bottles of pills have not "fixed" a thing.

In other words; this was recommended to my daughter at age 11, in 1999 and I dare say if there was a scan such as this that was not a scam, the pscyh wards would be empty and no one would suffer mental health issues.

I do wish Carlat's article was longer, and in more detail with thoughts on this issue/topic.

Anyone rebutting the SPECT here(pro)most likely has a vested interest in the product, not unlike a pharma drug rep or VNS salesman.

I think you are attacking a straw man, Dr. Carlat. Dr Amen is not making diagnoses on the basis of SPECT alone- he is using it to supplement an excellent and comprehensive diagnostic interview . I think, in general Amen clinic clinicians, have a good idea of what they are dealing with , before the results of the SPECT scan are read- but there are times when the scan probably reveals something unexpected and very important. The scans I think are very useful in encouraging compliance with medication, convincing patients that they really do have a brain disease. I have found Dr. Amen to be a tireless champion of neural plasticity- and this to me is a bigger contribution to the field than his SPECT scans- nutritional therapies, supplements , exercise do change the brain in good ways. His books have been very useful for my patients. He is not the snake oil salesman that you have painted him to be- that makes for good copy in Wired magazine- but it's not true. FWIW, I have no financial interest or relationship to the Amen clinic.

Also, Dr. Carlat, in fairness, to Dr Amen and your readers, you ought to disclose how much Wired paid you for the story. Dr. Amen has every right to make a profit from his clinic- the fact that thousands of people have paid thousands of dollars for his treatment doesnt bother me. He is obviously providing something of value to his patients- market forces being what they are, his clinic seems to have thrived where other brain imaging clinics such as Brain Matters, have not. To reiterate, the Amen Clinics are not selling brain scans - they are selling a different way to see and treat psychiatric patients. There is no harm in that, and most of the stone throwers, I think, envy his success in some capacity.

Parents have asked about this evaluation for their kids with ADHD. I replied, nothing beats a 10-Item Conners' Rating Scale, filled out in a minute, by teachers who know the student. That is true for diagnosis, and for the tracking of treatment response.

This is a rare instance where I have refused to attack insurance companies for not covering testing.

If parents have a spare $10K, I have suggested spending it on productive structured activity by the child or for future educational enrichment.

If one bases a test on the EEG, theoretically, one is measuring the activity of the outer centimeter of brain surface, then averaging it, massaging it, mapping the statistical results. Mapping gives the impression of some anatomical imaging. It is mapping of mathematical results. That it might be useful or even real requires duplicated proof by people without financial interest in the test.

As to popularity, anything alternative to the bad news and frustrations of standard diagnosis treatment will find adherents.

I picked up the newest book by Dr. Amen and immediately had some of the same questions that have been posed here. Nowhere in his book does he mention the fact that the SPECT scans involve, what to me is, scary amounts of radiation. And the price is no laughing matter either. Even if I thought it would greatly help me to get these scans, I would never have the money.

But that's not the real reason I picked up the book. I wanted to educate myself on how to lose weight and feel better about myself without spending anymore time on gadgets and snake-oil salesmen's tricks.

So leaving aside the scans for a moment, what's to be said about the supplements he proposes using? Are they safe in the amounts he suggests? Have they been shown in studies to do what he claims they do? And I would like to see a study or two of the long-term effects of brain injury/trauma, as I have been in two car accidents. And the multiple sections of the book that discuss brain injury don't seem to say much. Other that "don't do anything that can hurt your brain".

I'm still learning how to use this newly acquired critical thinking skill after years of taking everything at face value, so I've enjoyed reading this article as a counter-point to the book.

to the doubting shrink....just because you can't find research on medline, another wholly controlled establishment does not mean the research has not been done. Remember over a hundred and so years ago doctors were ridiculing the practice of hand washing to prevent the spread of invisible germs, well at least until the mortality rate of pregnant mothers dramatically declined...research seems to always be years ahead than practice, due to the narrow mindedness of short sighted doctors, no matter what field, who are entrenched in standard of care practices rather than being progressive thinkers who truly desire to solve a problem to their best ability rather than only masking or perpetuating it. Modern western medicine is wonderful for its mechanics, they fix broken bones, do by pass etc...but for everything else that has a pill , they do nothing to get one of the meds. There is no prevention, no cure, just maintenance....

I have never been to this clinic, thank fully I have no need for it. But,, this Carlat guy should have better things to do with his time, being helpful in his own field (I missed what sort of doc he is), rather than bashing innovation. since when has making a living become a crime...MacDonald's is poisoning america every day, yet no one complains Carlat should interview patients to see whether or not they have benefited rather than making his own uninformed biased conformist conclusions: really, he may learn something.

I'm a 56 year old caucasian male who was diagnosed with ADHD 5 years ago. My ADHD went undiagnosed until then despite consultation with nine different psychiatrists and psychologists.

Since my diagnosis, my life has turned around. I've received 3 promotions in the past 5 years (and would have been promoted again this past year, but for the current recession). My relationship with my wife has improved dramatically. And my income has doubled, to the $125,000 range.

I'm writing you because my ADHD was diagnosed at the Amen Clinic in Virginia. It seems unlikely to me that the objective improvements in my life are due to the placebo effect.

It is of course true that SPECT (and other neuroimaging techniques) don't lead to a diagnosis in the same way that an radiological image of a fractured tibia does. But that's not the crucial issue. Rather, the question is whether Dr. Amen's use of SPECT enables better diagnosis and treatment than other approaches.

It is inarguable that in my case SPECT played a crucial role in enabling an accurate diagnosis and treatment of my ADHD--I've since consulted with an independent, "conventional", highly respected psychiatrist specializing in ADHD, and he confirmed the diagnosis.

While I share concerns about his commercialism, that commercialism is hardly limited to Dr. Amen--opthamologists often own laser eye treatment centers, and many dermatologists sell cosmetics. I'm sure you can think of more comparable examples.

I'm writing in the hope that you may develop a somewhat more open-minded attitude toward Dr. Amen's work.